INNOFLUOR PHENYTOIN ASSAY SYSTEM— 510(k) K955562

Name: FDA 510(k) clearance K955562
Creator: U.S. Food and Drug Administration
Published: 1996-01-24

Substantially Equivalent

Oxis Intl., Inc.

FDA 510(k) clearance K955562 for INNOFLUOR PHENYTOIN ASSAY SYSTEM, Substantially Equivalent on 1996-01-24. Applicant: Oxis Intl., Inc.. Device class: 2.

Clearance details

Applicant: Oxis Intl., Inc.
Product code: Code LGR
Device class: Class 2
Regulation: 21 CFR 862.3350
Advisory panel: Clinical Toxicology
Date received: 1995-12-06
Decision date: 1996-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

Download summary PDF View on FDA.gov ↗

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